Our mid-sized medical device client is adding a Sr.Clinical Research Associate to the team.CRA is responsible for initiating and overseeing clinical centers to ensure the successful conduct of acti...Show moreLast updated: 22 days ago
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Quick Apply
Must be available for orientation on Monday, March 17th at 7am MUST BE COMPLIANT BY MARCH 10TH.Show moreLast updated: 11 days ago
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Remote
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Twin Cities metropolitan area wh...Show moreLast updated: 12 days ago
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Custom Search Inc.Minneapolis, MN, US
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Our mid-sized medical device client is adding a Sr.Clinical Research Associate to the team.CRA is responsible for initiating and overseeing clinical centers to ensure the successful conduct of acti...Show moreLast updated: 14 hours ago
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PRA Health SciencesMN, US
As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
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Inspire Medical SystemsGolden Valley, MN, US
Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA).
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Children's MinnesotaMinneapolis, Minnesota
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Humana Inc.Minneapolis, MN, US
Full-time
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Clinical Assistant, Associate, Full Professor - FNP
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Children's Hospitals and Clinics of MinnesotaSaint Paul, MN, United States
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This is where you save and sustain lives.At Baxter, we are deeply connected by our mission.No matter your role at Baxter, your work makes a positive impact on people around the world.You’ll feel a ...Show moreLast updated: 30+ days ago
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ActalentMinneapolis, Minnesota, USA
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Worldwide Clinical TrialsMinnesota, USA
Requisition Number7991Employment Type : Regular.Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutica...Show moreLast updated: 30+ days ago
Clinical Associate (1.0 FTE) - Infusion Center
Hennepin HealthcareMN-Minneapolis-Downtown Campus
$20.80–$25.48 hourly
FTE) - Infusion Center(241564).Hennepin Healthcare is an integrated system of care that includes HCMC, a nationally recognized Level I Adult Trauma Center and Level I Pediatric Trauma Center and ac...Show moreLast updated: 30+ days ago
Our mid-sized medical device client is adding a Sr. Clinical Research Associate to the team. The Sr. CRA is responsible for initiating and overseeing clinical centers to ensure the successful conduct of active clinical studies. The Sr. Clinical Research Associate will ensure that clinical centers perform the clinical study according to the study protocol and regulatory standards by qualifying, training, monitoring, and overseeing study conduct at multiple clinical centers.
Your role with the company :
Identify and assess the suitability of clinical study centers for participation in clinical trials
Train clinical centers on the clinical study protocol, data collection, and good clinical practices
Site Management : Communicate directly with clinical centers to maximize enrollment, ensure quality and timely data capture, and answer study-related questions
Assist in mentoring Junior monitors
Perform remote and on-site monitoring visits at participating clinical study centers to ensure the safety of study patients, the reporting of accurate study data, and appropriate study management at the clinical study center
Document site visits by preparing visit reports and follow-up letters to the clinical study centers
Assist clinical centers with the preparation of IRB / EC submissions
Collect and archive study-related documentation and correspondence
Communicate monitoring and site management updates to the internal clinical team
Assist with the development of the clinical study Monitoring Plan
Develop training materials and other study-related documentation
Maintain clinical monitoring tracking tools for each clinical study
Assist with other clinical-related duties as assigned
Document product and therapy field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed
Complete training requirements and competency confirmations as required for this position within the required timeline
Comply with applicable quality system procedures / policies and make suggestions for continuous process improvement
Desired Profile :
Bachelor's Degree (BA or BS) preferred; Science Degree preferred
Previous experience in clinical research (minimum 3 -5 years required), specifically monitoring and site management
Previous training and understanding of GCP and 21 CFR 812 required
Ability to travel up to approximately 30% required (about 2x / month)
Experience with clinical study documentation, clinical data, and data capture institutional review boards